T06002.006 Viva E System Onsite Training Workbook Eff Date 09-13-21

Viva-E® System
Onsite
Training Workbook
Siemens Healthineers
Viva-E System
Onsite Training Workbook
Viva-E System T06002.006 Effective Date: 09/13/21

© 2021 Siemens Healthineers Inc. All rights reserved.
This manual, and the software described in this manual, are copyrighted. No part of this may
be copied, reproduced, translated, or reduced to any electronic medium or machine-
readable form without the prior written consent of Siemens Healthineers.
EMIT, Syva, Viva-E, Viva-Jr, and V-Twin are registered trademarks of Siemens Healthineers.
All other trademarks are the property of their respective owners.
ii Viva-E System
Table of Contents
1: Welcome
2: Reagent Loading
3: Daily Start Up
4: Sample Processing
5: Calibration and Controls
6: Data/System Backup and Restore
7: Sample Processing II
8: Maintenance
9: Calibration and Control Review
10: Troubleshooting
11: Presentation Information
12: Resources
Viva-E System iii

iv Viva-E System
Welcome
1 Welcome
Welcome to Training
Siemens Healthineers Training would like to welcome you to the onsite training
for the Viva-E System.
This course is designed to provide the skills needed to operate and properly maintain the
Viva-E System.
Our staff welcomes the opportunity to present this training program to you.
Viva-E System 1-1

Welcome
Course Objectives
Upon completion of this course, you will be able to:
• Identify components of the Viva-E System.
• Navigate the system software.
• Order and run calibration, controls and samples.
• Evaluate calibrations, controls, and sample results.
• Define the EMIT® principle.
• Perform data and system back up procedures.
• Use the instrument’s Operator’s Manual.
• Perform maintenance procedures.
• Perform basic troubleshooting.
1-2 Viva-E System

Welcome
Training Agenda
Morning Afternoon
Day 1
System Overview Lunch Calibration/Controls
Good Laboratory Practice Data/System Backup and Restore

Discussion
STAT Sample Processing
Reagent Loading
Daily Startup
Sample Processing
Day 2
EMIT Principle Discussion Lunch Interpret Instructions for

Use (IFU)
Daily Startup
Navigate Additional System
Software Screens
System Maintenance
Weekly
Troubleshooting
Monthly
Quarterly
Evaluation
As Needed
Graduation
Calibration and Control Review
Viva-E System 1-3

Welcome
1-4 Viva-E System

Welcome
Viva-E® System Onsite Training

Course Validation Checklist
The participant places a checkmark beside the competency when it is completed.
When all competencies are checked, the instructor and participant sign and date
below as a record of completion.
Topics Competencies Completed

System Overview Identify major hardware components
Reagent Loading Navigate to the Reagent Info Screen
Identify reagent positions
Place reagent bottles in correct positions
Daily Startup Perform Daily Startup tasks
Process controls
Calibration and Controls Navigate software to request calibration
and controls and assign to the sample
rotor
Pipette / pour calibrators and controls
into cups and place in pediatric adaptors
Load and process calibrators and controls
Evaluate calibrations to accept or reject
results
Evaluate control results
Describe the QC screen
Sample Processing Navigate software to order samples and
assign to the sample rotor
Pipette / pour samples into tubes
Load and process samples

Evaluate sample results
Data/System Backup and Perform a data backup
Restore
Perform a restore point system backup
View Historic Results
Viva-E System 1-5

Welcome
Sample Processing II Request a STAT sample

Rerun positives
EMIT® Principle Describe the methodology of the EMIT®

reagents
Maintenance Perform weekly maintenance

Describe monthly maintenance
Perform quarterly maintenance
Perform as needed maintenance
Troubleshooting Resolve troubleshooting scenarios
Operator’s Manual Describe the Operator’s Manual
Information for Use (IFU) Describe the IFU
Navigating the Software Navigate additional software screens
1-6 Viva-E System

Welcome
Instructor: __________________________________________________
Student: __________________________________________________
Date: __________________________________________________
What was most helpful to you during this program?
How can we improve this program to make it more meaningful to you?
Viva-E System 1-7

Reagent Loading
2 Reagent Loading
Viva-E System 2-1

Reagent Loading
References
• Viva-E® System Operator’s Manual
• Viva-E® System Quick Reference Guide
Objectives
Upon completion of this exercise, you will be able to:
• Navigate the Reagent Info screen.
• Identify reagent positions according to the Reagent Info screen.
• Correctly place reagents on the instrument.
• List additional information that is displayed on the Reagent Info screen.
2-2 Viva-E System

Reagent Loading
Scenario: All onboard reagent bottles have expired and need to be replaced.
Reagent has been poured into new bottles and need to be placed onboard the
instrument.
Navigate to the Reagent Info Screen

1. How do you access the Reagent Info screen?
Identify Reagent Positions According to the Reagent Info Screen

1. List the positions that the THC reagents were placed in.
2. List the positions that the COC reagents were placed in.
Place Reagents on the Instrument

1. Are R1 reagents placed in the larger reagent positions, or smaller reagent
positions?
List additional information that is displayed on the Reagent

Info Screen
Viva-E System 2-3

Daily Maintenance
3 Daily Maintenance
Viva-E System 3-1

Daily Maintenance
References
Objectives
• Perform daily maintenance.
• Document daily maintenance on the daily maintenance checklist.
• Request and process controls
3-2 Viva-E System

Daily Maintenance
Perform Daily Maintenance

1. When should you refill the water container?
2. What type of water must be used to fill the water container?
3. What is added to the water container to make it treated water?
4. Describe how to evaluate the Blank Rotor Results Sheet?
5. How many days can reagent bottles be stored onboard the instrument?
6. What is the purpose of the HCL and Needle Rinse solution?
7. What is the purpose of performing a fill system?
8. After completing daily maintenance, what must be performed prior to sample

processing?
Process Controls
1. Why are controls processed prior to samples?
Viva-E System 3-3

Calibration and Controls
4 Calibration and Controls
Viva-E System 4-1

References
Objectives
• Process calibrations.
• Process controls.
• Evaluate calibration and control results.
4-2 Viva-E System

Process Calibration for All Tests

1. According to the quick reference guide, what should be done prior to ordering
a new calibration?
2. From the main menu, which option is selected to order a calibration?
3. What does a calibrator level highlighted in orange indicate on the worklist?
4. When do you need to calibrate?
Note: Calibrations and controls can be ordered at the same time.
Process Controls
1. On the worklist, what color indicates that a calibrator or control has been
assigned to the sample rotor?
2. List two scenarios when it is required to run controls.
Evaluate Calibration and Control Results

Note: The software will prompt you when your calibration is ready to be
evaluated.
1. Describe how to evaluate a new calibration.
2. How does an operator determine that control results are acceptable?
3. Where can you find the quality control expected separation, or ranges for any
test?
4. What is the expected control separation for level 0 and level 5 for Cocaine?
5. What are the acceptable ranges for Validity level 3 and Validity level 4?
Viva-E System 4-3

Sample Processing
5 Sample Processing
Viva-E System 5-1

Sample Processing
References
Objectives
• Order and process samples.
• Evaluate sample results.
5-2 Viva-E System

Sample Processing
Scenario: Samples have just been collected and require a comprehensive drug
screen. Process 5 samples for all tests.
Load and Process Samples

1. From the main menu, what option is used to order samples?
2. After ordering the first sample, what option is used to save and add another
sample?
3. Once ordered, can samples be placed anywhere in the sample rotor?
4. What option is selected to begin sample processing?
Evaluate Sample Results

1. On the worklist, what color indicates samples are completed and ready to
unload?
2. What option is used to view sample results?
3. Using the software, how do you remove completed samples from the sample
rotor?
Viva-E System 5-3

Data/System Backup and Restore
6 Data/System Backup and Restore
Viva-E System 6-1

References
Objectives
• Create a restore point/system backup.
• Perform a data backup.
• View historic results.
• Discuss system/data restore.
6-2 Viva-E System

Scenario: The weather channel has announced a severe thunderstorm warning in

your area. During a recent hurricane, the entire county lost power. A drug court in
your area lost all their patient and system data. Your facility avoids the potential loss
of information by performing regular backups.
Create a Restore Point/System Backup

1. What information is saved when a restore point is made?
2. When would a system restore need to be performed using a restore point?
Perform Data Backup

1. What type of information is stored during a data backup?
2. Where is it recommended to store data backups and restore points?
View Historic Results

1. From the main menu, what options are selected to view historic results?
Viva-E System 6-3

Sample Processing II
7 Sample Processing II
Viva-E System 7-1

References
Objectives
• Request samples for DAT and validity testing.
• Request a STAT sample.
• Evaluate results.
• Rerun positive samples
• Distinguish the difference between a diluted and substituted sample
using Creatinine results.
7-2 Viva-E System

Scenario: 5 samples have been requested for DAT and validity testing. Before
beginning sample processing, Judge Judy calls and states that she needs the testing
performed on sample #5, as soon as possible.
Request Qualitative DAT and Validity Samples

1. Order 5 samples
2. Which option from the main menu did you use to order samples?
3. Request Sample #5 as STAT

4. What is the advantage of choosing the sample type as STAT?
5. Run samples.
Rerun Positive Samples

1. For all samples that have positive results, pour a fresh sample from the
collection cup and re measure all positive tests.
2. Why do you pour a fresh sample when rerunning positive samples?
Distinguish the Difference Between a Diluted and a Substituted

Sample
1. What does a creatinine result of <2.0 mg/dL indicate?
2. What does a creatinine result of <20.0 mg/dL but >2.0 mg/dL indicate?
Viva-E System 7-3

Maintenance
8 Maintenance
Viva-E System 8-1

Maintenance
References
Objectives
• Perform weekly maintenance.
• Discuss monthly maintenance.
• Perform quarterly maintenance.
• Perform as needed maintenance.
• Document all maintenance tasks.
8-2 Viva-E System

Maintenance
Perform Weekly Maintenance

1. From the main menu, what are the steps to perform a Needle Rinse?
2. What solution is used to rinse the probe?
Discuss Monthly Maintenance

1. What is the cleaning solution used for monthly maintenance?
2. Which bottle should be cleaned first during monthly maintenance?
Perform Quarterly Maintenance

1. When tightening the screw, where is the dryer block located?
Perform As Needed Maintenance

1. When does the cuvette rotor need to be replaced?
Note: Document all maintenance on the correct maintenance checklist.
Viva-E System 8-3

9 Calibration and Control Review
Viva-E System 9-1

References
Objectives
• Order, process, and evaluate calibrations.
• Describe the difference between evaluating DAT and validity controls.
• Resolve calibration and control failures.
9-2 Viva-E System

Scenario: Your Field Service Engineer performed a PM (Preventative Maintenance)

on your analyzer today. To ensure your analyzer is operating properly, you must
calibrate and run controls on all tests.
Order and Process Calibration and Controls

1. Print previous calibrations.
Note: For calibrations with multiple points, you must select Display Calibration first.
2. From the main menu, which option is used to order calibrations and controls?
Evaluate Calibration and Controls

1. What is used to evaluate a new calibration?
2. Describe how to evaluate DAT controls.
3. Describe how to evaluate validity controls.
4. Describe any issues that occurred while calibrating or running controls.
5. How did you resolve the issues listed above?
Viva-E System 9-3

Troubleshooting
10 Troubleshooting
Viva-E System 10-1

Troubleshooting
References
Objectives
After completing this exercise, you will be able to:
• Resolve system error messages.
10-2 Viva-E System

Troubleshooting
Scenario: You have just arrived in the lab. Your supervisor explains that your
colleague had a family emergency and went home. It is up to you to complete
testing of the remaining specimens.
Request and Process Samples for Opiate

1. Request 3 samples to be processed.
Resolve a System Error

1. What is the instrument alerting you to?
2. How did you resolve this issue?
Viva-E System 10-3

Presentation Information
11 Presentation Information
Viva-E System 11-1

Good Laboratory Practices

SAMHSA - Substance Abuse and Mental Health Services Administration
Bio Safety
• Gloves, lab coats
• Wear protective eyeglasses
• Wash hands
• No application of make-up or lip-balm while testing
• No eating or drinking in testing area
Specimen Handling
• Correctly identify samples
• Label collection cups accurately
o Name of client
o Client initials or signature
o Date and time of collection
• Dispose of urine and waste appropriately
Tubes and Pediatric Cups

• Correctly identify samples
• Label calibrator, control, or sample tubes and cups first, then pour or pipette. Do
so by one of the following 2 methods:
o Use bar codes
o Label appropriately
Appropriate Specimen Storage

Urine:
• It is recommended to store in the refrigerator for up to 30 days.
• May be stored up to 7 days at room temperature.
• Freeze if stored for more than 7 days at room temperature or 30 days
refrigerated.
• ETOH samples must be frozen after 3 days per IFU.
11-2 Viva-E System

Reagent Handling
• Do not mix reagents or different lot numbers.
• Label reagent bottles that are onboard the analyzer with assay name and lot
number.
• Mark the date opened on reagent bottles, calibrators, and controls.
• Do not use kits or reagents beyond the expiration date.
• Store kits and reagents according to package insert/IFU, typically refrigerated.
• Manage your reagent inventory so the reagent with the earliest expiration date
may be used first. For example, rotate the newly received product in back of the
older product.
• Do not order more supplies than needed especially calibrators or controls.
Basic Procedures
• Use provided tools:
o Operator’s Manual
o Quick Reference Guide
o Viva-E System Onsite Training Workbook
Basic Operation
• Perform Daily Maintenance
• Run quality control (QC) prior to running samples.
• Calibrate when necessary.
Results
• Accurately record results.
• Include operator signature or initials, date, and time.
• Rerun/confirm all positives.
Viva-E System 11-3

Calibrations and Controls
Calibrators and Controls

• Packaged as calibrators/controls
• Urine containing known amounts of drug or drug metabolite
• Liquid and ready to use
• Stored between 2°C and 8°C
Calibrations: What You Need to Know

• Every assay needs to be calibrated.
• The calibrator level used is dependent on the assay cutoff value for example
Cocaine 150 uses calibrator Level 2.
• Absorbance readings are different for each assay being tested
• Instrument processes calibrators the same as client samples.
Calibrations: How it Works

• Calibrators are run in duplicate, and the average is the stored and reported
calibrator absorbance reading.
• Absorbance readings (rates) are obtained and stored by the instrument each
time the assay is calibrated and overwrites the previous calibration.
• Calibrator duplicate difference must be less than or equal to the limit set in the
instrument software.
• Client samples are compared to calibration absorbance readings (rates) for each
assay.
• Samples results (positive/negative) are compared to the calibrator cutoff level:
11-4 Viva-E System

o Results at or above the cutoff level are “presumptive positive” for the drug.
o Results below the cutoff level are “negative” for the drug.
Note: Negative does not mean “drug free.”
Calibrators and Controls

• Cutoff: The qualitative value of an analyte that is used to decide whether the
result or sample is positive or negative
o Cutoffs for work place drug testing (federally mandated cutoffs) have
been set by Department of Health and Human Services (DHHS) / and
Substance Abuse and Mental Health Services Administration (SAMHSA).
o Cutoffs for nonregulated drugs are set by manufacturers.
• Pos Control: contains more drug than the Cutoff; higher rate than cutoff and
separation must be acceptable for drug or drug metabolite.
• Neg Control: no drug present; rate lower than the cutoff and the separation
must be acceptable for drug or drug metabolite.
Viva-E System 11-5

Evaluating Qualitative Controls

Acceptable Separations
Separations
• Must be greater than the expected separation.
• Are calculated by the instrument- for the Positive control by subtracting the
cutoff rate from the control rate. For the Negative control by subtracting the
control rate from the cutoff rate.
• The smaller the separation, the greater the chance of false positives or
negatives.
Note: Separations should be consistent from day to day
• Must verify that Level 0 is negative and Level 5 is positive.
11-6 Viva-E System

Frequency
Calibration: When Do You Calibrate/Recalibrate?
• Establish a routine (lab-dependent; recommendation is once per week).
• New reagent lot.
• When control separations are not met (need to be greater than or equal to
expected separations).
• After maintenance such as a new lamp, a PM call, a new syringe or when
replacing the cuvette rotor
• According to manufacturer IFU.
Controls: When Do You Run Controls (QC)?

• Every day after daily maintenance and before testing samples
• After calibration
• Recommended after filling reagent bottles during a run or while testing
• Run samples only after controls are acceptable
Viva-E System 11-7

What is EMIT®?
EMIT is an acronym for Enzyme Multiplied Immunoassay Technique
Immunoassays
• Immunoassays use antibodies produced by the immune system. Antibodies bind
to a specific antigen or closely-related group of antigens.
• The ability to produce antibodies that specifically bind to drugs or their
metabolites contributes to antibodies being the principle component of the
EMIT® system.
• In EMIT® assays, antibodies are created specifically for drugs or drug metabolites
to detect the presence of a specific drug.
• The antibodies are in Reagent 1.
Enzyme Label
• The production of the enzyme-labeled drug is the critical step in the
development of an EMIT assay.
• Enzymes are catalysts for making chemical changes. When provided with a
substrate they create color-producing byproducts that can be measured in the
reaction.
• The enzyme in Reagent 2 is linked to the same drug or drug metabolite that the
antibody is created for and the second key component in the EMIT reaction.
2 Key points
• Antibodies attack Antigens (The drug).
• Enzymes eat the food (Substrate) to make the reaction happen.
11-8 Viva-E System

EMIT Reagents
Reagents
Reagent 1
• Antibody
• Substrate (G6P) = Food
• Coenzyme (NAD)
• Buffer
Reagent 2
• Enzyme-labeled drug or drug metabolite
• Buffer
Viva-E System 11-9

Enzymatic Reaction
• The assays are based on the competition between the drug or drug metabolite
in the urine sample and drug labeled with the enzyme (G6PDH) for antibody
binding sites.
• When the enzyme-labeled drug reacts with the substrate, it produces hydrogen.
• The co-enzyme NAD (nicotinamide adenine dinucleotide) is converted to NADH.
NADH possesses a unique property: it absorbs light at 340 nm and changes in
absorbance can be measured photometrically.
• Enzyme activity decreases upon binding to the antibody, so the drug
concentration in the urine sample can be measured in terms of enzyme activity.
11-10 Viva-E System

POSITIVE REACTION
Step 1 Step 2 Step 3
Sample E
NAD
Drug
Drug metabolite
metabolite
G6P (Food)
Reagent 1 Reagent 2
NAD
Drug metabolite
Drug metabolite G6P (Food)
Cuvette
If there is drug metabolite in the

sample, enzyme-bound drug E G6P (Food)
metabolite is free to react with Drug metabolite
G6P (food) to produce H Drug metabolite
(hydrogen), which then reacts
with NAD to produce color
NAD H
(NADH).
Viva-E System 11-11

NEGATIVE REACTION
Step 1 Step 3
Step 2
NAD E
Sample
Drug
G6P (Food) metabolite
Reagent 1 Reagent 2
NAD
NAD
E
G6P (Food)
Drug
metabolite
G6P (Food)
Cuvette
If there is no drug metabolite in
the sample, enzyme-bound drug
metabolite will attach to the
antibody and will not be available G6P (Food)
to act on G6P (food) to produce
H (hydrogen). Therefore, there is E
E
no color (NADH) produced.
NAD
11-12 Viva-E System

EMIT Multiplied Reaction in a Positive Sample

When the drug is present in the sample:
• Most of the antibody will bind the drug.
• Less of the antibody will be available to bind with the enzyme.
• More of the enzyme will remain unbound or free.
• Free enzyme will produce more NADH, thus increasing the absorbance of light,
at 340nm, in the reaction solution.
• More of the drug leads to more NADH and a higher rate. The NADH is directly
proportional to the amount of drug present.
NOTE: The EMIT reaction provides a “presumptive positive” result.
EMIT Multiplied Reaction in a Negative Sample

When no drug is present in the sample:
• The antibody will bind the enzyme-labeled drug.
• Less of the enzyme will remain unbound or free.
• Very little NADH will be produced, and thus only a small absorbance of light, at
340nm, in the reaction solution.
• Less of the drug leads to less NADH and a lower rate. The NADH is directly
proportional to the amount of drug present.
Viva-E System 11-13

Syva Validity Test (SVT)

Urine Adulteration
There are 3 ways to adulterate a urine sample:
1. In-vivo adulteration is when the donor ingests something to alter the drug
concentration or the urine characteristics in a way that interferes with the drug
test.
2. In-vitro adulteration involves tampering with the sample through adding
something to the sample. The goal of the additive is to interfere with the drug
tests or degrade the drug molecule to where it is not detected by the drug
screen and/or confirmation.
3. Substitution includes exchanging the sample with a sample that is drug-free.
Do you think this statement is true?
“Give me 2 hours and a drinking fountain, and I can beat your drug test.”
Yes, it is true. Water loading or dilution is the most effective way of interfering with
the concentration of drugs in a sample.
• After drinking 0.5 L of water, Creatinine drops from 190 mg/dL to 50 mg/dL in 1
hour
• After drinking 1 L of water, Creatinine drops to 20 mg/dL in 1 hour
A diluted sample is defined as a sample with a Creatinine value less than 20 mg/dL
and a specific gravity (sG) value less than 1.003.
In-Vivo (ingests substance to escape detection)

In-vivo products marketed to adulterate a urine sample also come with directions,
such as:
• Recommend no “toxins” (drugs) 24 to 72 hours prior to testing
• Use vitamin B-12 or B-complex to restore color
• Typically ingest with a quart to a gallon of water
It is the water that is important. Drinking water is the most effective technique to
dilute drug concentration in urine.
In-Vitro (externally adds substance to escape detection)
In-vitro techniques include:
• Diluting the sample with water
• Diluting the sample with common household substances
• Diluting the sample with commercially-marketed products
Substitution
• Concealed container
11-14 Viva-E System

o Clean urine in a condom

o Heat with a hand warmer
• Catheterization
• Obtain clean urine:
From another individual
From an animal
Synthetic urine
Prevention Methods
• Removal of bulky clothing such as coats, sweatshirts or remove all clothing if
necessary
• Prohibit handbags and briefcases in the restroom where samples or other
products may be stored
• Eliminate hot water
• Have Client Wash Hands prior to collection
• Add bluing agent into the toilet
• Removal of soap
• Observed Collection
• Less than 1 hour of time between test notification and collection time
• Limit the amount of water from 8 oz. to 12 oz
Detection Methods
Physical appearance
• Color should be clear or yellow
• Odor should not smell like bleach or ammonia, and so forth
• Temperature: Take immediately. Should be 90.5°F to 98.9°F (32.5°C to 37.7°C)
“Why Should I Test For Adulteration?”

• Mandated by the Department of Transportation
• Mandated by SAMHSA (effective as of 11/01/04)
• Referenced in European Laboratory Guidelines and UK Laboratory Guidelines
Available Syva Validity Products

• pH Validity
• Creatinine Validity
• Specific Gravity Validity
• Nitrite Validity
Viva-E System 11-15

• Oxidant Validity
Frequently Used Validity Products and Typical Expected Ranges

• pH between 4.5 and 9.0
• Specific gravity between 1.0010 and 1.0250
• Creatinine between 20 mg/dL and 400 mg/dL
Substance Abuse and Mental Health Services Administration (SAMHSA)

Criteria for identifying adulterated samples:
Adulterated: A urine specimen that contains a substance that is not a normal
constituent or an endogenous substance at a concentration that is not a normal
physiological concentration.
o pH less than 3 or greater than or equal to 11
o Nitrite greater than or equal to 500 µg/L
o Presence of glutaraldehyde, bleach or peroxide (must ID)
• Diluted: A urine specimen with Creatinine and specific gravity values that are
lower than expected for human urine. This requires both of the following:
o Creatinine greater than or equal to 2 mg/dL but less than 20 mg/dL
o Specific gravity greater than 1.0010, but less than 1.0030
• Substituted: A urine specimen with Creatinine and specific gravity values that
are so diminished or so divergent that they are not consistent with normal
human urine. This requires both of the following:
o Creatinine less than 2mg/dL
o Specific gravity less than or equal to 1.001, or greater than or equal to
1.0250
Department of Human Health Services (DHHS)

Invalid: A urine specimen that contains an unidentified adulterant, contains an
unidentified interfering substance, has an abnormal physical characteristic, or has
an endogenous substance at an abnormal concentration that prevents the
laboratory from completing testing or obtaining a valid drug test result.
The use of validity testing in conjunction with Syva DAT testing is an effective
method to achieve a high level of accuracy in a drug test.
11-16 Viva-E System

Resources
12 Resources
Viva-E System 12-1

Resources
12-2 Viva-E System

Resources
Viva Analyzers Consumables List
Part # Description Comments
10445339 0.1N HCL (Hydrochloric Acid) 1L

10445341 0.1N NaOH (Sodium Hydroxide) 1L
10445223 Sodium Hypochlorite Solution (Needle Rinse) 1L
10445247 System Solution 1L
10484938 15 mL Bottle with Lid 20/pkg

10484937 30 mL Bottle with Lid 20/pkg
10445345 Cuvette Reaction Rotor 3/pkg
10445220 Sarstedt Frosted Plastic Tubes (13X75) 500/pkg
10445229 Sample Cup 2 mL 1,000/pkg
357524 Transfer Pipette 3 mL 500/pkg
10720620 Syringe 1 mL (Reagent) Large

10720619 Syringe 100 µL (Sample) Small
10332628 Water Filter 1/pkg

10336657 Mixer Belt 1/pkg
10457084 Pediatric Adapter Set 10/pkg
6001-962 Wash Arm Block Assy 1/pkg
10285189 Wash Arm Dryer Block Assy 1/pkg
10452401 Sample Arm Piercing Rod 1/pkg
10452400 Wash Arm Piercing Rod 1/pkg
10452605 Screw for Dry Block Assy 1/pkg
Viva-E System 12-3

Resources
What You Need to Know About Handling Your Reagents

• All reagents have a lot number (for example, A3) and expiration date. Lot
numbers should be documented on the reagent bottles that are placed on the
analyzer.
• Only open 1 reagent kit at a time. Keep your “kits in use” separately in a bin.
When the last of 1 of the reagents is depleted, the kit is history. Discard what is
left. They are not used equally.
• When filling the bottles, never fill above the “shoulder.” The level sensing can
be affected. For all the Drugs of Abuse Tests, you should get about 140
deliveries when the bottle is filled to the shoulder.
• Be sure to fill the R1 bottle with R1 and the R2 bottle with R2.
• When topping off reagents swirl gently to mix the reagents and allow time for
the reagents to equilibrate
• Never top off or refill the onboard bottle with a different lot number.
• The large and small bottles that you pour the reagents into need to be replaced.
The maintenance checklist advises to change the bottles monthly. You can
document the bottle onboard (BOB) date on the bottle.
• The Creatinine reagent should be capped and placed in the refrigerator at the
end of the day. The R1 reagent can be very unstable, and this will extend the
stability. When the stability is compromised, the calibrator abs values will be
decreased. The Creatinine calibrators are only good for 21 days.
• You do not need that much calibrator and QC in the small sample cups. Up to
the first line or a little below is adequate.
• If you need to recalibrate Alcohol, you will need to redispense the Alcohol
calibrators and QC due to evaporation.
• When running Alcohol it may be recommended to use tubes not cups for all
calibrators, controls and samples
• For Drugs of Abuse testing use polypropylene tubes not polystyrene to reduce
THC adherence to the plastic tubes.
Other Important Tips

• Perform Backing up of System Database and Archive Files in case of a computer
crash.
12-4 Viva-E System

Resources
GLOSSARY
Absorbance -The amount of light absorbed by matter in solution.

Aliquot - A representative sample of a larger quantity.
Amphetamine - A stimulant, also known as Speed, Ice, Crystal, Amp, Pharmaceutical
names include Benzedrine, Dexedrine.
Antibodies - Proteins generated by the immune system in reaction to foreign
invaders. They remove the invaders from the system. Each antibody is made
specifically to recognize only one invader.
Antibody Binding -The antibody attaches to the matching site on the invader prior
to removing it from the body. The Emit assays use antibody binding to recognize
drugs.
Audible Alarm -The sound the Viva analyzer uses to alert the operator. Press the
space bar to stop the alarm.
Barbiturates - A depressant, also known as downers reds, yellow jackets
Pharmaceutical names Amobarbital, Phenobarbital . Used as sedatives, hypnotics.
Benzodiazepine - A depressant also known as bennies Pharmaceutical names
Valium, Oxazepam, Xanax (Alprazolam).
Buffer -The buffer contained in the Emit reagents provides a consistent
environment in which the test can take place.
Calibrate -To determine, by measurement or comparison with a standard, the
correct value of each assay reading.
Calibrator - A sample that contains a known amount of drug or drug metabolite and
is used to compare unknown samples with. Calibrators are used as a comparison to
measure the drug in a sample much as a ruler is used to measure height.
Cannabinoid (THC) - A hallucinogen also known as marijuana, weed, hash,
Pharmaceutical name Marinol.
Carryover - The contamination of one sample on an instrument by a previous
sample. Carryover occurs if some of the first sample (typically a sample with a very
high concentration of the drug) is carried over by the probe to the next sample
causing it to test positive when it should have tested negative
Catalyst - A substance that modifies and increases the rate of a chemical reaction
without being consumed in the process.
Cocaine - A stimulant also known as Coke, Crack, nose candy.
Cocaine Metabolite - The substances which the liver breaks cocaine down to, the
primary cocaine metabolite is benzolecgonine.
V-Twin System 12-5

Resources
Coenzyme - A heat-stable organic molecule that must be loosely associated with an

enzyme for the enzyme to function.
Concentration Units - Units of measurement that tell how much of a solid is
suspended or dissolved in a liquid. The Emit tests use nanograms (one billionth of a
gram) of drug per milliliter of liquid for units (ng/mL).
Control - A sample that contains either a known amount of drug (positive) or no
drug at all (negative) and is used to check the system. The system consists of the
analyzer, chemistry (reagents, calibration) and the operator. These control values
must meet minimum separation specifications.
Cutoff - The qualitative value of an analyte that is used to decide whether the result
or sample is positive or negative
• Cutoffs for work place drug testing (federally mandated cutoffs) have been set
by (Department of Health and Human Services (DHHS) / and Substance Abuse
and Mental Health Services Administration (SAMHSA).
• Cutoffs for nonregulated drugs are set by manufacturers.
Cutoff Calibrator - Urine or serum standard containing the amount of drug that will
serve as the cutoff between positive samples and negative samples.
Cross reactivity -The measure of the assays affinity for a specific drug. This may be
affected by protocol, time, temperature and other factors all of which is not clearly
understood.
Cuvette rotor - The compartment where the reaction (sample and reagents) occurs
and is read by the photometer.
DAT or DAU - Drugs of Abuse Testing or Drugs of Abuse.
Deionized Water - Water from which all charged species or ionizable organic and
inorganic salts have been removed via an ion exchange process.
Distilled Water - Water that has been freed of dissolved or suspended solids and
organisms by distillation.
Drug of Abuse - A drug that is taken for non-medicinal reasons, usually for mind-
altering effects.
EMIT - Enzyme Multiplied Immunoassay Technique
Enzymes - Proteins produced by living organisms that function as biochemical
catalysts in Iiving organisms.
Equilibrate -To reach equilibrium, a state in which all acting influences are canceled
by others, resulting in a stable, balanced, unchanging system.
Immune Reaction -The reaction of the immune system to a foreign invader, which
involves the production of antibodies which bind to and remove the invader from
the body.
12-6 V-Twin System

Resources
Immune System – A complex system of cells by which an organism protects itself

against foreign pathogens.
Immunoassay - A test that analyzes and identifies a substance on the basis of its
antigenic actions.
Lyophilized - Freeze dried.
MDMA Methylenedioxymethamphetamine, Ecstasy - A stimulant also known as
Molly, XTC, Adam.
Metabolite - A substance that has been transformed from another substance by the
body's metabolic processes.
Methadone - An opioid also known as Fizzie.
Methamphetamine - A stimulant, also known as speed, crystal, crank, and by
pharmaceutical names such as Desoxyn and Methedrine.
Methaqualone - A depressant also known as Ludes, Quad, Quay, Pharmaceutical
name Quaalude.
Microliter µL - Unit of measurement meaning one millionth of a liter.
Milliliter (mL) - One thousandth of a liter
Molecule -The smallest amount of a substance which can exist alone, a chemical
combination of two or more atoms which form a specific chemical substance
NAD - Nicotinamide adenine dinucleotide (NAD) is the substrate upon which the
enzyme G6PDH acts. In the Emit technology NAD is converted to NADH. The amount
of this reaction is dependent on the amount of drugs in the sample and is measured
by the analyzer.
Nanogram (ng) - One billionth of a gram.
Opiate - A sedative narcotic containing opium or one or more of its derivatives, also
known as heroin, smack, chasing the tiger. Pharmaceutical names include,
morphine, codeine, oxycontin.
Phencyclidine (PCP) - a hallucinogen, also known as Angel Dust, Peace, and Pill.
Originally an animal tranquilizer.
Pipette - Small glass or plastic tube, used to transfer small amounts of liquid. Or the
act of transferring small amounts of liquid.
Plasma -The clear, yellowish fluid portion of blood in which the particulate
components are suspended.
Probe -The part of the analyzer that transfers reagents and samples to a cuvette.
Propoxyphene - An analgesic, sold as Darvon, Darvocet.
Qualitative - The presence or absence of an analyte in a sample.
Quantitative - The concentration or amount of analyte in a sample.
V-Twin System 12-7

Resources
Rate - Change in absorbance over time

Reagent - A substance used to produce a chemical reaction so as to detect measure,
or produce other substances.
Reconstitute -To return a freeze-dried substance to its former hydrated state by
adding water.
Semi-quantitative - the preliminary concentration of the analyte in the sample, to
be confirmed by a more specific alternative chemical method such as Gas
chromatography/mass spectrometry.
Sample - Often used interchangeably with specimen; urine or blood given by a
donor that will be used for testing.
Sample Cup -The small container that holds sample on the instrument.
Sample Identification Number (ID) -The unique number assigned to each sample.
Sample Rotor -The instrument tray that holds the calibrators, controls or sample
containers and probe wash.
SAMHSA - Substance Abuse and Mental Health Services Administration, the
agency which establishes certification program for laboratories engaged in urine
drug testing for Federal agencies. Establishes scientific and technical guidelines for
Federal agencies workplace drug testing programs.
Sensitivity -The capability of an antibody to connect with its antigen even when the
antigen is present in low concentrations.
Serum -The clear liquid that separates from blood when it is allowed to clot
completely, it is therefore blood plasma from which the fibrinogen has been
removed in the process of clotting.
Specificity -The special affinity of an antibody for just one antigen, the less likely it is
to connect with a different kind of antigen, the more specific it is.
Substrate - A substance upon which an enzyme acts.
Syringe - Aspirates and dispenses sample or reagent.
Ultraviolet light -The range of wavelengths covering 4-400 nanometers (nm), NADH,
one of the products of the Emit chemistry when drugs are present, can be detected
at 340 nm, the wavelength at which the analyzer reads the reaction.
12-8 V-Twin System

Viva-E® Daily / Weekly Maintenance Checklist
Month/Year: ______________________________ Serial Number: ______________________________
Daily Maintenance 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Fill water container with 10 liters of DI
water and 25 mL of System Solution (pn
3203-063)
Empty waste containers (follow local
safety instructions and regulations for
working with and disposing of potentially
infectious material)
Check rotor blank results for SD errors.
Change cuvette rotor if necessary (pn
6002-706)
Check for sufficient reagent volume.
(Reminders: Discard expired reagent.
Replace onboard reagent bottles every 4
weeks or when a new lot of reagent is put
into use )
Fill HCl bottle on the reagent rotor with
0.1 N HCl (pn 5621-02)
Fill tube in W position on sample rotor with
Needle rinse (Sodium Hypochlorite
Solution pn 7668)
Remove measurement disk cover and
inspect wash arm, mixer belt and
measurement rotor
Check that the reagent rotor compartment
is being cooled
Archive Results – software can be setup
to automatically perform this function
Perform an instrument Fill System and
inspect syringes
Operator’s Initials
Weekly Maintenance Week 1 Week 2 Week 3 Week 4 Week 5

®
F10 Exit the Viva-E program and perform a
Windows computer Restart. Start Viva-E® program
Perform needle rinse cleaning procedure
(Sodium Hypochlorite Solution pn 7668)
Initial and Date
Viva-E® Monthly / Quarterly / Semi-annual Maintenance Checklist
Year: ____________ Serial Number: ____________________
Monthly Maintenance Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
Clean water and waste containers with 0.1 N NaOH
(pn 5636-02). Afterwards rinse water container several
times with deionized or distilled water.
®
F10 Exit the Viva-E program, properly shutdown the
computer, and turn the instrument’s power off. Wait 10
seconds. Turn on the instrument’s power, start the
®
computer and start the Viva-E program
Initial and Date
Quarterly Maintenance Quarter 1 Quarter 2 Quarter 3 Quarter 4

Replace drying block on wash arm (pn 6001-963).
Initial and Date
Semi-annual Maintenance Half year 1 Half year 2

Replace mixer belt (pn 3064-041).
Replace water filter (pn 3066-083).
Run the clean system procedure.
Initial and Date
As Needed Date Date Date Date Date Date

Change cuvette rotor (pn 6002-706) after 10,000 tests or
after receiving SD errors on the daily rotor blank.
Replace lamp.
Initial and Date

T06002.006 Viva E System Onsite Training Workbook Eff Date 09-13-21

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5: Calibration and Controls

6: Data/System Backup and Restore

9: Calibration and Control Review

11: Presentation Information

Viva-E System iii

Viva-E System 1-1

1-2 Viva-E System

System Overview Lunch Calibration/Controls

Good Laboratory Practice Data/System Backup and Restore

EMIT Principle Discussion Lunch Interpret Instructions for

Viva-E System 1-3

1-4 Viva-E System

Viva-E® System Onsite Training

Topics Competencies Completed

Load and process samples

Viva-E System 1-5

Sample Processing II Request a STAT sample

EMIT® Principle Describe the methodology of the EMIT®

Maintenance Perform weekly maintenance

1-6 Viva-E System

What was most helpful to you during this program?

How can we improve this program to make it more meaningful to you?

Viva-E System 1-7

Viva-E System 2-1

2-2 Viva-E System

Navigate to the Reagent Info Screen

Identify Reagent Positions According to the Reagent Info Screen

Place Reagents on the Instrument

List additional information that is displayed on the Reagent

Viva-E System 2-3

Viva-E System 3-1

3-2 Viva-E System

Perform Daily Maintenance

2. What type of water must be used to fill the water container?

3. What is added to the water container to make it treated water?

4. Describe how to evaluate the Blank Rotor Results Sheet?

6. What is the purpose of the HCL and Needle Rinse solution?

7. What is the purpose of performing a fill system?

8. After completing daily maintenance, what must be performed prior to sample

Viva-E System 3-3

4 Calibration and Controls

Viva-E System 4-1

4-2 Viva-E System

Process Calibration for All Tests

2. From the main menu, which option is selected to order a calibration?

3. What does a calibrator level highlighted in orange indicate on the worklist?

4. When do you need to calibrate?

Note: Calibrations and controls can be ordered at the same time.

2. List two scenarios when it is required to run controls.

Evaluate Calibration and Control Results

2. How does an operator determine that control results are acceptable?

Viva-E System 4-3

Viva-E System 5-1

5-2 Viva-E System

Load and Process Samples

3. Once ordered, can samples be placed anywhere in the sample rotor?

4. What option is selected to begin sample processing?

Evaluate Sample Results

2. What option is used to view sample results?

Viva-E System 5-3

6 Data/System Backup and Restore